- June 4, 2025
Senator Marshall Questions FDA’s Acting Director About Steps to Remove Harmful Ingredients from OTC Drugs and Replace Animal Testing with AI
Washington – U.S. Senator Roger Marshall, M.D. (R-Kansas) today questioned Dr. Jacqueline Corrigan-Curay, Acting Director at the Center for Drug Evaluation and Research for United States Food and Drug Administration (FDA), during the most recent Senate Committee on Health, Education, Labor, and Pensions (HELP) hearing.
Click HERE or on the image above to watch Senator Marshall’s full exchange with Dr. Corrigan-Curay.
Highlights from the hearing include:
On inactive ingredients in over-the-counter drugs:
Senator Marshall: “Let’s talk about inactive ingredients. As you know, the OTC monographs only list active ingredients. A lot of MAHA [Make America Healthy Again] moms out there are concerned about inactive ingredients, artificial flavors, sweeteners, etc. What is going on in the world of over-the-counters [medications] as far as identifying those inactive ingredients, and is there an effort to get the ones that are not safe out of these over-the-counters?”
Dr. Corrigan-Curay: “Thank you for that question. We certainly, anytime we identify that there’s an issue with an inactive ingredient, we would review it and we would look to make changes in that inactive ingredient. We do have ways and guidances. We just did one on color additives to allow firms to a pathway if they want to change their inactive ingredients or their color additives, and we can get back to you with more information.”
Senator Marshall: “Alright, let’s talk about… studies. More and more, it would seem that AI can replace animal studies. And probably even more accurate. So often you read, well, what works, what happened in monkeys and dogs, has nothing at all to do with the biology of human beings. Is there any effort in your department to convert over to AI and do less animal studies?”
Dr. Corrigan-Curay: “Thank you. We’re engaged on the new initiative to reduce animal studies in monoclonal antibodies, and we previously have been working on looking for alternatives to animal studies. We already do. We no longer use animal studies for eye irritation or skin irritation, and we certainly will, you know, are looking at both AI as we’re looking at these non-animal approaches. There are still challenges in coming out with validated studies, when you’re looking at you’re looking for an effect that would affect multi-organ systems. That doesn’t mean that we won’t get there, and we’ll continue to work on that.”
Senator Marshall: “Okay, again, if there’s a way that you could measure that and show us – we were doing so many animal studies five years ago, this is how many we did last year, this is how many we’re doing this year. You know, prove to me that you’re making progress in that, that would be very helpful.”
Dr. Corrigan-Curay: “We can get back to you.”
###
